In order to introduce a group-wide standardized Quality Management Software the Aenova Group, one of the world’s leading companies in the pharmaceutical and health care industry, relies on the life science expertise of DHC Business Solutions.
Regulatory compliance requirements in the foreground
Pharmaceutical companies must handle business-critical documents such as Standard Operating Procedures (SOPs) in a way that complies with legal regulations and regulatory requirements. This has far-reaching implications for safety, health and the environment, as well as for maintaining business operations as a whole.
Only if 21 CFR Part 11 is complied with and all cGxP requirements are taken into account, can defect reports (Form 483) or even a warning letter from the U.S. Food and Drug Administration (FDA) be prevented.
DHC VISION offers the optimal solution for this. Differentiated workflows and solid “SOP Closed Loop Processes” ensure that documents such as SOPs can be easily created, securely reviewed, traceably approved and released, and distributed in a target-oriented manner. At DHC VISION, comprehensive document control is carried out in an integrated management environment that establishes reliable cross-connections to other important task areas. After all, documents cannot just simply be distributed; it is just as important that employees receive content training. As an integrated management system, DHC VISION therefore builds an important bridge between document control on the one hand and task- and role-specific training management on the other.
Corrective and preventive actions matter
Discrepancies and failures are registered as anomalies in the product quality. They trigger detailed analyses and diagnoses of their causes. Measures to eliminate the causes must be initiated and their effect subsequently evaluated. These steps are essential for effective and reliable action or CAPA management: “Corrective Actions”, i.e. corrective measures to rectify errors, are best combined with “Preventive Actions”.
DHC VISION makes this connection and thus contributes significantly to the efficiency of operational and quality-related processes. Standardized, traceable and standard-compliant solutions are available – not only for the systematic investigation of discrepancies, but also for complaints and such cases that are “Out of Specifications (OOS)”. And electronic signatures and detailed audit trails ensure compliance with 21 CFR Part 11.
Industry Quality Metrics and Quality Oversight are central
A company like the Aenova Group, with 28 locations worldwide, needs a precise overview of the current quality status at all times. “Corporate Quality Governance” must be observed. This can only be achieved through an efficient reporting system and continuous monitoring of quality assurance measures.
For this purpose, the Aenova Group uses, among other things, the powerful reporting and dashboards of the DHC VISION Analytics Framework for different target groups, which filters and condenses the essential KPIs, “overdues” and “subjects of attention” in order to enable the monitoring and control of quality targets on this basis.
Group-wide roll out
The high dynamics in the corporate development of the Aenova Group with organic growth and corporate acquisitions requires the continuous harmonization and standardization of the methods, processes and documents relevant to quality management. In the QM domains SOP, Training and CAPA Management, there is a comprehensive best practice knowledge transfer between the companies, so that standardization and simplification up to corporate knowledge management is achieved almost incidentally in connection with the global roll-out of DHC VISION.
Validation made simple
Today, IT systems play a central role in the development and production of medicinal products and medical devices. If such a system is used in critical business areas, the company must provide documented proof that the system functions according to predefined specifications as part of a software validation. The system must also be kept permanently valid during operation. In sectors such as the pharmaceutical industry or medical technology, which are subject to health authority regulations (GxP), this is ensured by the validation of computerized systems (CSV) according to specifications or predefined industry standards (e.g. FDA Guidelines, PICs, GAMP®5). DHC VISION Validation Accelerators are used to minimize the validation expenses. These are templates and process models from the validation plan, Part 11 analysis, URS, via the test case definitions and specification to the validation report.
Dr. Andreas König, Senior Vice President Corporate Quality & HSE at the Aenova Group, “Trust in the company and the people involved, a target-oriented project methodology for introduction and a powerful solution for the life science industry were the decisive criteria for Aenova to work with DHC Business Solutions..”
Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions, adds: “With Aenova Group as a client, we will be able to further refine and expand our market position and understanding of processes and digital transformation in the regulated environment. We look forward to collaborating with them further.”
The Aenova Group is one of the world’s largest pharmaceutical contract manufacturers. In Europe, the company is the market leader in the development, production and marketing of medicinal products and food supplements. Aenova has a total of 28 locations in nine European countries, Asia and the USA. More than 4,400 employees contribute to the success of the group of companies (C.P.M., Dragenopharm, EVP, Haupt Pharma, Swiss Caps, SwissCo, Temmler).
You can find more information about Aenova Group at www.aenova-group.com